Heidelberg, March 11, 2026 – TolerogenixX, a clinical-stage biopharmaceutical company developing personalized cell therapies to induce sustained immune tolerance in organ transplantation and autoimmune diseases, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its lead cell therapy candidate MIC-Lx for individualized immuno-suppression in living donor kidney transplantation. The PRIME scheme supports medicines addressing serious diseases with significant unmet medical needs and provides early and enhanced regulatory interaction with the EMA to accelerate clinical development and patient access. 

Kidney transplantation is the preferred treatment for end-stage renal disease, yet patients require life-long systemic immunosuppressive therapy to prevent organ rejection. These treatments are associated with significant side effects, including infections, malignancies and metabolic complications. TolerogenixX’s MIC-Lx therapy (Modified Immune Cells for Living-donor transplants) aims to induce donor-specific immune tolerance, potentially allowing transplant recipients to significantly reduce chronic immunosuppression. 

The PRIME designation follows a positive assessment by the Committee for Advanced Therapies (CAT) and endorsement by the Committee for Medicinal Products for Human Use (CHMP) during its February 2026 meeting. According to the EMA assessment, available clinical and non-clinical data support the hypothesis that modified donor immune cells treated with a cytostatic agent may induce a tolerogenic immune state in transplant recipients. 

Clinical Phase I and ongoing Phase II studies in renal transplant patients with follow-up data of up to 10 years support the proposed mechanism of action and indicate:

- absence of donor-specific antibody responses
- substantial reduction of immunosuppressive therapy
- fewer opportunistic infections. 

5-year follow-up data from the Phase I study were published in Frontiers in Immunology in 2023 and showed long-lasting donor-specific immune modulation accompanied by a sustained increase in regulatory B lymphocytes. 

"The EMA PRIME designation is an important recognition of the potential of our MIC technology to improve the current treatment paradigm in transplantation," said Prof. Dr. Matthias Schaier, CEO of TolerogenixX. "Our goal is to enable donor-specific immune tolerance and reduce the burden of chronic immunosuppression for transplant patients. Clinical data generated so far indicate that our MIC therapy may provide an effective treatment option for kidney transplant recipients while reducing the side effects typically associated with long-term immunosuppression." 

The Company plans to publish data from an ongoing Phase IIb trial in the first half of 2027.

About TolerogenixX 

TolerogenixX is a privately held biopharmaceutical company developing novel, personalized therapies to induce antigen-specific immune tolerance in transplantation and autoimmune diseases. Its proprietary MIC (modified immune cells) technology aims to modulate the immune system in a targeted manner, potentially reducing the need for long-term systemic immunosuppression. 

The Company’s lead candidate MIC-Lx has completed a Phase Ib clinical trial (TOL-1) in kidney transplant recipients demonstrating sustained safety and tolerability after a single administration while preserving normal immune responses. A Phase IIb study (TOL-2) is currently ongoing. 

TolerogenixX was founded in 2016 and is headquartered in Heidelberg, Germany.

About MIC treatment

MIC treatment is a personalized cell therapy approach to modulate the immune system via a novel mode of action to achieve specific and sustained immune tolerance. It could not only benefit transplant recipients, but also patients with autoimmune diseases such as https://www.tolerogenixx.com/systemic lupus erythematosus and multiple sclerosis. 

MIC production is fast, safe, and effective. Using cells obtained by leukapheresis, MIC can be manufactured within 24 hours. Due to a standardized procedure, MIC production can be scaled up easily and made available globally using the proprietary approach developed by TolerogenixX.

Contact

TolerogenixX GmbH
Prof. Dr. med. Matthias Schaier

Im Neuenheimer Feld 162
D-69120 Heidelberg/Germany

schaiernospam@tolerogenixX.com
Tel. +49 162 2638005

akampion
Dr. Ludger Weß / Ines-Regina Buth
Managing Partners

info@akampion.com

Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68

Heidelberg, July 06, 2023 – TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, today announced that in the TOL2- Phase IIb study in renal transplant patients TolerogenixX has received green light by the Safety Board to initiate the B arm of the study. This arm consists of patients receiving minimal immune suppression drugs, reducing tacrolimus and weaning off enteric-coated mycophenolate sodium and methylprednisolone completely. The study enrolls 63 transplant couples consisting of a donor and a transplant recipient, respectively. The protocol has been published in BMJ Open.

Furthermore, the company is publishing 5-year follow-up data of a Phase I trial of its MIC-Lx cell therapy. The results published in Frontiers in Immunology demonstrate that the use of TolerogenixX's MIC cell therapy prior to transplantation provides long-lasting donor-specific immunosuppression and a sustained, significant increase in regulatory B lymphocytes.

TolerogenixX's MIC-Lx cell therapy (Modified Immune Cells for Living-donor transplants) is a curative cell treatment to induce donor-specific immune tolerance in transplant recipients and also bears potential for autoimmune patients. In living donor transplantation such as kidney transplantation, peripheral blood mononuclear cells (PBMCs) of the donor are harvested by leukapheresis. Donor PBMCs are then modified by the Company's proprietary MIC technology. The resulting cell therapy product, MIC-Lx, subsequently is administered intravenously to the transplant recipient prior to transplantation.

TolerogenixX has already reported positive results from the 1 and 3 year follow-up of 10 transplant recipients of its TOL-1 Phase I trial initiated at Heidelberg University Hospital. All patients who had received MIC infusions prior to kidney transplantation in the TOL-1 clinical trial had a favorable clinical course 3 years after surgery. In the current publication, the Company reports that these 10 MIC patients continued to have excellent clinical outcomes at 5 years, with stable renal graft function, no donor-specific human leukocyte antigen (DSA) antibodies or acute rejections, and no severe opportunistic infections. In comparison, a retrospectively matched control group receiving standard immunosuppressive therapy had a higher incidence of donor-specific HLA antibodies (log rank P = 0.046) and more opportunistic infections (log rank P = 0.033).

Importantly, MIC patients continued to show a lack of anti-donor T lymphocyte reactivity in vitro and a high titer of potent regulatory B-cells crucial for a functional immune system until year 5 after surgery. Specifically, this holds true for the four patients who had been infused the highest cell number 7 days before surgery and who received low immunosuppressive medication during follow-up.

"We are very pleased about these results," said Prof. Dr. Christian Morath, CSO of TolerogenixX. "Five years after transplantation, tolerance is still present. Patients are immunologically better protected, show no severe concomitant symptoms and were able to significantly reduce immunosuppressive therapy."

"These are exciting and clinically highly relevant data," added Prof. Dr. Matthias Schaier, CEO of TolerogenixX. "We see that our MIC therapy opens the perspective of a transformative and effective treatment option for kidney transplant recipients. It can reduce the side effects of conventional chemical immunosuppression and provide for lasting immune suppression without making the transplant recipients more susceptible to opportunistic infections. We are now conducting a Phase IIb study with a larger series of patients treated with MIC and a reduced immunosuppressive drug regimen. Our preclinical studies also demonstrate great potential in autoimmune disease"

On the back of these promising results, TolerogenixX also reported a EUR 7 million second closing of its Series A financing round now totaling EUR 11.6 million.

"We are very pleased that we were able to add EUR 7 million to our Series A financing round," Schaier said. "In the current financing environment, this is a further validation of our approach, enabling us to successfully complete our Phase II program."

New investor in the round is DB Speciality GmbH & Co. KG, Neu Ulm, an investment company of the health care specialist Dr. Dietrich Bruchmann. Dr. Bruchmann is a very experienced investor with highest expertise in the life science sector. Existing investors include Kalodion Fond I, CventureS, Nisus, HTGF, Dr. Dr. Dorow, Dr. Dr. Fakler and Biotech Mountains BV.

The deal was initiated by CoInvest Corporte Finance GmbH, Planegg. CoInvest acted as lead arranger and financial adviser to the transaction.

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About TolerogenixX

TolerogenixX is a privately held biopharmaceutical company focusing on the development of novel, personalized therapies for autoimmune patients and transplant recipients. The Company´s proprietary MIC (modified immune cells) treatment is designed to suppress unwanted immune responses in the body, thereby enabling a targeted, specific and sustained immune tolerance. While the current standard of care, i.e. traditional immunosuppression, is only addressing symptoms and has serious side-effects, MIC treatment is tackling the roots of immune responses and provides increased effectiveness, little or no side effects, significantly increased quality and length of patients´ lives as well as decisive cost advantages.

TolerogenixX´ lead compound MIC-Lx has successfully completed a clinical Phase Ib trial in kidney transplant recipients, demonstrating sustained safety and tolerability after a single application while retaining normal immune responses.

The Company was founded in 2016 and is based in Heidelberg, Germany.

About MIC treatment

MIC treatment is a personalized cell therapy approach modulating the immune system via a novel mode of action to achieve a specific and sustained immune tolerance. It can not only be applied to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.

MIC production is fast, safe, and effective. MIC can be manufactured within 24 hours, using cells obtained by leukapheresis. Due to a standardized procedure, MIC production can be scaled up easily and made available globally using the proprietary approach developed by TolerogenixX.

Contact

TolerogenixX GmbH

Prof. Dr. med. Matthias Schaier

Im Neuenheimer Feld 162

D-69120 Heidelberg/Germany

schaiernospam@tolerogenixX.com

Tel. +49 162 2638005

akampion

Dr. Ludger Weß / Ines-Regina Buth

Managing Partners

info@akampion.com

Tel. +49 40 88 16 59 64

Tel. +49 30 23 63 27 68